Intraocular shunt inserter

ABSTRACT

A system for deploying an intraocular shunt can include an intraocular shunt inserter and a deflector component that is releasable attachable to a distal end portion of the inserter. The inserter can include a housing having a distal end portion and a needle extending from the distal end portion. The deflector component can have a needle guide configured to receive the needle of the inserter therein. The deflector component can be coupled to the inserter in order to permit the needle guide to bend the needle and maintain the needle in a bended configuration.

BACKGROUND

Glaucoma is a disease of the eye that affects millions of people.Glaucoma is associated with an increase in intraocular pressureresulting either from a failure of a drainage system of an eye toadequately remove aqueous humor from an anterior chamber of the eye oroverproduction of aqueous humor by a ciliary body in the eye, Build-upof aqueous humor and resulting intraocular pressure may result inirreversible damage to the optic nerve and the retina, which may lead toirreversible retinal damage and blindness.

Glaucoma may be treated in a number of different ways. One manner oftreatment involves delivery of drugs such as beta-blockers orprostaglandins to the eye to either reduce production of aqueous humoror increase flow of aqueous humor from an anterior chamber of the eye.Glaucoma filtration surgery is a surgical procedure typically used totreat glaucoma. The procedure involves placing a shunt in the eye torelieve intraocular pressure by creating a pathway for draining aqueoushumor from the anterior chamber of the eye. The shunt is typicallypositioned in the eye such that it creates a drainage pathway betweenthe anterior chamber of the eye and a region of lower pressure. Suchfluid flow pathways allow for aqueous humor to exit the anteriorchamber.

SUMMARY

The importance of lowering intraocular pressure (IOP) in delayingglaucomatous progression is well documented. When drug therapy fails, oris not tolerated, surgical intervention is warranted. There are varioussurgical filtration methods for lowering intraocular pressure bycreating a fluid flow-path between the anterior chamber and thesubconjunctival tissue, in one particular method, an intraocular shuntis implanted with an inserter by directing a needle, which holds theshunt through the cornea, across the anterior chamber, and through thetrabecular meshwork and sclera, and into the subconjunctival space. See,for example, U.S. Pat. No. 6,544,249, U.S. Patent ApplicationPublication No. 2008/0108933, and U.S. Pat. No. 6,007,511, theentireties of which are incorporated herein by reference.

Existing inserters may have components that move inadvertently and maynot always provide desired levels of precision and feedback during aprocedure. During a procedure, an operator may not be able todifferentiate between the different stages of the insertion process,such as shunt insertion and needle retraction. This may require theoperator to manually and/or visually review steps of the procedure,which increases the time that a careful and attentive operator mustdevote to each step of the procedure. As such, this can increase surgerytime, potentially cause greater trauma to the patient, and neverthelessbe reliant on tactile or visual perception of components withoutcertainty that certain milestones or positions have been achieved.

Accordingly, the present disclosure contemplates these problems,provides solutions to these problems, and relates to the realizationthat precision can be increased while reducing operator effort andsurgery time, in some embodiments, implementing certain advantageousfeatures in a shunt inserter.

Some embodiments disclosed herein provide an intraocular shunt inserterhaving an actuator that that permits the operator to deliver and/orrelease an intraocular shunt. The inserter can be configured to providea frictional track or resistance against which an operator can move theactuator, whether sliding or rotating. This resistance to movement canensure that the inserter exposes or releases the shunt only whenintended by the operator. Further, the resistance can tend to cause theoperator to operate the inserter using a greater degree of precision andcontrol.

Optionally, some embodiments can comprise one or more feedbackcomponents that can serve as indicators of motion or completion of stepsin the procedure. For example, the inserter can comprise an actuator,whether sliding or rotating, that can provide one or more audible clicksand/or barriers of increased resistance that can serve as signals to theoperator that a certain position or step of the procedure has beencompleted. In some embodiments, a slider component can contact against afirst engagement structure or indicator on the inserter to create anaudible click or barrier of increased resistance. Continued movementbeyond the click or barrier of increased resistance can allow theoperator to move the slider component towards a second, third, fourth,or other engagement structure or indicator that can create an audibleclick or barrier of increased resistance to signal to the operator thatthe slider component has been advanced to a predetermined locationand/or that additional positions or steps of the procedure have beencompleted. Accordingly, the inserter can advantageously provide improvedprecision and feedback to an operator.

Further, some embodiments disclosed herein can optionally provide aninserter with a bended shaft or needle that can provide greater tactilecontrol of the inserter and improved clearance during a procedure. Theneedle can extend from a distal end portion of the inserter and comprisea bend at which a longitudinal axis of the needle is redirected along adifferent axis. The bend can enable an operator to more easilymanipulate and/or perceive the position of a bevel of the needle duringthe procedure. Thus, some embodiments can advantageously permit anoperator to more easily visually verify that a certain result has beenachieved. For example, by rotating the bevel of the needle, an operatorcan “tent” the conjunctiva of the eye, thereby facilitating placementand delivery of the intraocular shunt into a subconjunctival targetlocation. Further, the bend can cause a longitudinal axis of a housingof the inserter to be spaced at a greater distance apart from apatient's face during the procedure than compared tostraight-needle-type inserters.

For example, an inserter can include a housing and a slider component.The housing include a distal portion, a proximal portion, a longitudinalaxis extending between the distal and proximal portions, an interiorcavity, and an elongate slot extending along an outer surface of thehousing into the cavity. The slider component can be coupled to thehousing and positioned along the outer surface of the housing. Theslider component can be slidable along the elongate slot to operate theinserter. The slider component can include a guide tab disposed withinthe guide channel of the housing body. The slider component can alsoinclude a friction tab with a biasing member configured to urge againstthe housing body to urge the guide tab against the channel wall of theguide channel.

An operator can operate the inserter by urging the slider componentalong an axis of the inserter. The slider component can actuate adeployment mechanism of the inserter to deliver and release anintraocular shunt. In order to do so, the operator must overcome aninitial friction force provided by a friction tab of the slidercomponent against the housing. The operator can use the slider componentto advance a plunger of the inserter to urge the shunt within a lumen ofthe needle.

During operation of the inserter, an operator can receive tactile orhorrible feedback from engagement structures of the housing, forexample, as the friction tab moves across an engagement structure. Thefeedback can correspond to the position of the shunt relative to theneedle within the inserter. The feedback can be provided by adiscontinuity on the housing.

For example, in some embodiments, the inserter can generate an audiblesignal using a biasing member configured to engage a discontinuity ofthe housing body. The audible or tactile signal can indicate a positionof the slider component relative to the inserter and/or indicate aposition of the shunt or stage of shunt delivery.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding of the subject technology and are incorporated in andconstitute a part of this specification, illustrate aspects of thedisclosure and together with the description serve to explain theprinciples of the subject technology.

FIG. 1A is a schematic view of a procedure for implanting an intraocularshunt into an eye using an inserter, according to some embodiments.

FIG. 1B is a perspective view of an inserter for implanting anintraocular shunt into an eye, according to some embodiments.

FIG. 2 is a perspective, exploded view of the inserter shown in FIG. 1B,according to some embodiments,

FIG. 3 is a perspective, exploded view of a drive assembly of theinserter shown in FIG. 1B, according to some embodiments.

FIGS. 4A-4C illustrate a slider component of the inserter shown in FIG.1B, according to some embodiments.

FIG. 5 is a cross-sectional view of an inserter for implanting anintraocular shunt into an eye, according to some embodiments.

FIGS. 6A-6C are cross-sectional views of engagement structures of theinserter, according to some embodiments.

FIG. 7A is a perspective view of a sleeve mount of the drive assemblyshown in FIG. 3, having a straight shaft, according to some embodiments.

FIG. 7B is a perspective view of a sleeve mount of the drive assemblyshown in FIG. 3, having a bended shaft, according to some embodiments.

FIG. 8A is a perspective view of an inserter having an alignment guidefor providing a bend in the shaft of the inserter, according to someembodiments.

FIG. 8B is a perspective view of an alignment guide coupled to a sleeve,according to some embodiments.

FIG. 8C is a side view of an alignment guide coupled to a sleeve,according to some embodiments.

FIG. 9A is a front perspective view of another alignment guide,according to some embodiments.

FIG. 9B is a rear perspective view of the alignment guide of FIG. 9A,according to some embodiments.

FIG. 10A is a perspective view of an alignment guide coupled to a sleevewith a protective cap, according to some embodiments.

FIG. 10B is a side, cross-sectional view of a bevel protection devicereceived within a needle lumen of an inserter, according to someembodiments.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are setforth to provide a full understanding of the subject technology. Itshould be understood that the subject technology may be practicedwithout some of these specific details. In other instances, well-knownstructures and techniques have not been shown in detail so as not toobscure the subject technology.

Glaucoma is a disease in which the optic nerve is damaged, leading toprogressive, irreversible loss of vision. It is typically associatedwith increased pressure of the fluid (i.e., aqueous humor) in the eye.Untreated glaucoma leads to permanent damage of the optic nerve andresultant visual field loss, which can progress to blindness. Once lost,this damaged visual field cannot be recovered.

In conditions of glaucoma, the pressure of the aqueous humor in the eye(anterior chamber) increases and this resultant increase of pressure cancause damage to the vascular system at the back of the eye andespecially to the optic nerve. The treatment of glaucoma and otherdiseases that lead to elevated pressure in the anterior chamber involvesrelieving pressure within the anterior chamber to a normal level.9

Glaucoma filtration surgery is a surgical procedure typically used totreat glaucoma. The procedure involves placing a shunt in the eye torelieve intraocular pressure by creating a pathway for draining aqueoushumor from the anterior chamber of the eye. The shunt is typicallypositioned in the eye such that it creates a drainage pathway betweenthe anterior chamber of the eye and a region of lower pressure. Variousstructures and/or regions of the eye having lower pressure that havebeen targeted for aqueous humor drainage include Schlemm's canal, thesubconjunctival space, the episcleral vein, the suprachoroidal space,the intra-Tenon's adhesion space, and the subarachnoid space. Shunts maybe implanted using an ab externo approach (e.g., entering through theconjunctiva and inwards through the sclera) or an ab interno approach(e.g., entering through the cornea, across the anterior chamber, throughthe trabecular meshwork and sclera). For example, ab interno approachesfor implanting an intraocular shunt in the subconjunctival space areshown for example in Yu et al. (U.S. Pat. No. 6,544,249 and U.S. PatentApplication Publication No. 2008/0108933) and Prywes (U.S. Pat. No.6,007,511), the contents of each of which are incorporated by referenceherein in its entirety,

Some methods can involve inserting into the eye a hollow shaftconfigured to hold an intraocular shunt. In some embodiments, the hollowshaft can be a component of a deployment device that may deploy theintraocular shunt. The hollow shaft can be coupled to a deploymentdevice or be part of the deployment device itself. The deploymentdevices can include devices such as those as described in co-owned U.S.Pat. Nos. 9,585,790, 8,721,792, 8,852,136, and U.S. Patent ApplicationPublication No. 2012/0123434, filed on Nov. 15, 2010, the contents ofeach of which are incorporated by reference herein in their entireties.

As noted above, conventional deployment devices or inserters may notprovide desired levels of precision and feedback, requiring additionaloperator effort and surgical time. The present disclosure providesvarious embodiments of methods and devices that can enable an operatorto implant a shunt using an inserter with improved comfort, feedback andprecision while reducing surgical time. As used herein, the term “shunt”includes hollow microfistula tubes similar to the type generallydescribed in U.S. Pat. No. 6,544,249 as well as other structures thatinclude one or more lumens or other flow paths therethrough.

In accordance with some embodiments, the inserter can be advanced intothe eye via an ab-interno or an ab-externo approach. Thereafter, theshunt can be deployed from the shaft into the eye such that the shuntforms a passage from the anterior chamber into an area of lowerpressure, such as Schlemm's canal, the subconjunctival space, theepiscleral vein, the suprachoroidal space, the intra-Tenon's adhesionspace, the subarachnoid space, or other areas of the eye. The hollowshaft is then withdrawn from the eye. Methods for delivering andimplanting bioabsorbable or permanent tubes or shunts, as well asimplantation devices for performing such methods, are generallydisclosed in applicant's applications, including U.S. Patent ApplicationPublication Nos. 2012/0197175, 2015/0011926, and 2016/0354244, U.S.patent application Ser. No. 15/613,018, as well as in U.S. Pat. Nos.6,007,511, 6,544,249, 8,852,136, and 9,585,790 each of which areincorporated by reference in their entireties,

Some methods can be conducted by making an incision in the eye prior toinsertion of the deployment device. However, in some instances, themethod may be conducted without making an incision in the eye prior toinsertion of the deployment device. In some embodiments, the shaft thatis connected to the deployment device has a sharpened point or tip. Insome embodiments, the hollow shaft is a needle. Exemplary needles thatmay be used are commercially available from Terumo Medical Corp.(Elkington, Md.). In some embodiments, the needle can have a hollowinterior and a beveled tip, and the intraocular shunt can be held withinthe hollow interior of the needle. In some embodiments, the needle canhave a hollow interior and a triple ground point or tip.

Some methods can be conducted without needing to remove an anatomicalportion or feature of the eye, including but not limited to thetrabecular meshwork, the iris, the cornea, or aqueous humor. Somemethods can be conducted without inducing substantial ocularinflammation, such as subconjunctival blebbing or endophthalmitis. Somemethods can be achieved using an ab interna approach by inserting thehollow shaft configured to hold the intraocular shunt through thecornea, across the anterior chamber, through the trabecular meshwork,and into the intra-scleral or intra-Tenon's adhesion space. However,some methods may be conducted using an ab externo approach.

In some methods conducted using an ab interna approach, the angle ofentry through the cornea can be altered to affect optimal placement ofthe shunt in the intra-Tenon's adhesion space. The hollow shaft can beinserted into the eye at an angle above or below the corneal limbus, incontrast with entering through the corneal limbus. For example, thehollow shaft can be inserted from about 0.25 mm to about 3.0 mm abovethe corneal limbus. The shaft can be inserted from about 0.5 mm to about2.5 mm above the corneal limbus. The shaft can also be inserted fromabout 1.0 mm to about 2.0 mm above the corneal limbus, or any specificvalue within any of these ranges. For example, the hollow shaft can beinserted above the corneal limbus at distances of about: 1.0 mm, 1.1 mm,1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, or 2.0mm.

Further, in some embodiments, placement of the shunt farther from thelimbus at the exit site, as provided by an angle of entry above thelimbus, can provide access to more lymphatic channels for drainage ofaqueous humor, such as the episcleral lymphatic network, in addition tothe conjunctival lymphatic system. A higher angle of entry also resultsin flatter placement in the intra-Tenon's adhesion space so that thereis less bending of the shunt.

As discussed in U.S. Pat. No. 8,852,136, the entirety of which isincorporated herein by reference, in some embodiments, to ensure properpositioning and functioning of the intraocular shunt, the depth ofpenetration into the intra-Tenon's adhesion space may be important whenperforming some methods.

In some methods, the distal tip of the hollow shaft can pierce thesclera and intra-Tenon's adhesion space without coring, removing orcausing major tissue distortion of the surrounding eye tissue. The shuntis then deployed from the shaft. Preferably, a distal portion of thehollow shaft (as opposed to the distal tip) completely enters theintra-Tenon's adhesion space before the shunt is deployed from thehollow shaft.

In accordance with some embodiments, the hollow shaft can comprise aflat bevel needle, such as a needle having a triple-ground point. Thetip bevel can first pierce through the sclera and into the intra-Tenon'sadhesion space by making a horizontal slit. In some methods, the needlecan be advanced even further such that the entire flat bevel penetratesinto the intra-Tenon's adhesion space, to spread and open the tissue toa full circular diameter.

Further, in accordance with an aspect of some methods, the intra-Tenon'schannel can be urged open by the flat bevel portion of the needle sothat the material around the opening is sufficiently stretched and apinching of the shunt in that zone is avoided, thus preventing the shuntfrom failing due to the pinching or constriction. Full entry of the flatbevel into the intra-Tenon's adhesion space causes minor distortion andtrauma to the local area. However, this area ultimately surrounds andconforms to the shunt once the shunt is deployed in the eye.

In some embodiments, the inserter can function as a one-handed device inorder to allow an operator to keep their other hand on a fixation devicethat holds the eye, such as a hook. This can improve surgical controland placement accuracy and makes the surgery easier as well.

An illustration of a procedure for treating an eye 12 is shown in FIG.1A. FIG. 1A illustrates the use of a hook 14 for holding the eye 12 andan inserter 100 for introducing an intraocular shunt into the eye.

FIGS. 1B-9 illustrate further details of the inserter 100 shown in FIG.1A. The inserter 100 can be actuated using a single hand, thusfacilitating use of the inserter by an operator. The inserter 100 cancomprise a housing 102, a needle assembly 104, and a slider component106. As shown in FIG. 1B, the inserter 100 can be configured such thatthe slider component 106 is coupled to the housing 102 via guidechannels 111 and slidable along an elongate slot 110 of the housing 102.The slider component 106 can be selectively movable by an operator inorder to actuate movement of components of the needle assembly 104.

For example, when the slider component 106 moves distally along the slot110 (i.e., in a direction toward the needle assembly 104), the slidercomponent 106 can result in or cause a shunt (not shown) to be advancedwithin the needle assembly 104, and in some embodiments, released fromthe needle assembly 104. In accordance with some embodiments discussedfurther herein, movement of the slider component 106 can result intranslational and/or rotational movement of components of the needleassembly 104. The sliding movement of the slider component 106 can beconverted into rotational movement, which can thereafter be converted tomovement along a longitudinal axis of the inserter 100. One of thebenefits of this innovative and complex movement-conversion mechanism isthat it enables embodiments of the inserter to provide precise, measuredmovements of its components within a compact assembly.

As illustrated in FIG. 2, the needle assembly 104 can comprise a needlecomponent 120, a plunger 122, and a sleeve component 124. The needlecomponent 120 can comprise a 25 GA or 27 GA needle. The plunger 122 canbe slidably movable within a lumen of the needle component 120 along alongitudinal axis 178 of the inserter 100. Further, the needle component120 can be slidably movable within a lumen of the sleeve component 124along the longitudinal axis 178. Each of the needle component 120 andthe plunger 122 can be coupled to respective drive components of a driveassembly 130 disposed within the housing 102. When in the assembledstate, the inserter 100 can be configured such that the needle component120, the plunger 122, and the sleeve component 124 are aligned along orcoaxial with the longitudinal axis 178. Some drive assemblies foractuating a plunger and for withdrawing a needle of an inserter aredisclosed in U.S. patent application Ser. Nos. 13/336,803, 12/946,645,12/620,564, 12/946,653, 12/946,565, and 11/771,805 and U.S. Pat. No.9,585,790, the entireties of which are incorporated herein by reference.

Referring to FIGS. 2 and 3, the needle component 120, the plunger 122,and the sleeve component 124 can be operably coupled to the driveassembly 130 and/or the housing 102. For example, the needle component120 can be coupled to a needle mount 140. The needle mount 140 can befixedly coupled to a proximal end portion of the needle component 120such that rotational and longitudinal movement between the needlecomponent 120 and the needle mount 140 is restricted or prevented. Theneedle mount 140 can be enclosed within a distal end portion of thehousing 102 when the inserter 100 is assembled. Further, as illustratedin FIG. 3 and discussed further below, the needle mount 140 can becoupled to a needle driver 164 (and in the illustrated embodiment, via arotational adjustment component 300) of the drive assembly 130.

Further, as shown in FIG. 3, the plunger 122 can be coupled to a plungermount 142. The plunger mount 142, can be fixedly coupled to a proximalend portion or midsection of the plunger 122 to restrict or preventrotational and longitudinal movement of the plunger 122 relative to theplunger mount 142. Further, as illustrated in FIG. 3 and discussedfurther below, the plunger mount 142 can be coupled to a plunger driver162 of the drive assembly 130.

Furthermore, the sleeve component 124 can be coupled to a sleeve mount144. The sleeve mount 144 can be coupled to a proximal end portion ofthe sleeve component 124 so as to prevent rotational and longitudinalmovement between the sleeve component 124 and the sleeve mount 144. Thesleeve mount 144 can be coupled to a portion 148 of the housing 102, asdiscussed below.

As noted above, the needle component 120, the plunger 122, and thesleeve component 124 can be operably coupled to the drive assembly 130and/or the housing 102. Such coupling can occur via the needle mount140, the plunger mount 142, and the sleeve mount 144. In turn, theneedle mount 140, the plunger mount 142, and the sleeve mount 144 can becoupled to one or more drive components that engage with the driveassembly 134 to the housing 102.

In accordance with some embodiments, the drive assembly 130 can becoupled to the needle component 120 and the plunger 122 to actuatemovement along the longitudinal axis 178 of the needle component 120 andthe plunger 122 relative to the housing 102. For example, the driveassembly 130 can be configured to rotate or slide within the housing102. The drive assembly 130 can transfer a longitudinal or axial forcealong the longitudinal axis 178 to the needle component 120 and/or theplunger 122, independently or at the same time, to result in movement ofthe needle component 120 and the plunger 122 relative to the housing 102along the longitudinal axis 178.

As discussed herein, motion of the slider component 106 can result inmotion of the drive assembly 130 and thereby result in motion ofcomponents of the drive assembly 130 relative to the housing 102. Someembodiments can be configured such that the slider component 106 can belongitudinally movable or slidable along the longitudinal axis 178relative to the housing 102 in order to drive or result in linear motionof the needle component 120 and the plunger 122 and consequently ashunt.

As shown in FIG. 3, the drive assembly 130 can comprise a drivecomponent 160, a plunger driver 162, and a needle driver 164. In someembodiments, longitudinal or linear motion of the slider component 106along the longitudinal axis 178 can be converted to result in rotationof the drive component 160 of the drive assembly 130, which can then beconverted to result in longitudinal or linear motion of the needlecomponent 120 and the plunger 122 along the longitudinal axis 178relative to the housing 102. In accordance with some embodiments, motionof the components along the longitudinal axis 178 can be parallelrelative to the longitudinal axis 178.

FIG. 3 also illustrates an embodiment of the drive component 160. Thedrive component 160 can comprise a groove 170 that can be configured toengage with a corresponding protrusion (not shown) of the slidercomponent 106. Further, the drive component 160 can also comprise firstand second driving grooves 172, 174 that can be configured to slidinglyengage corresponding protrusions of the plunger driver 162 and theneedle driver 164. Thus, the slider component 106 can comprise aprotrusion 430 (shown in FIG. 4B), the plunger driver 162 can comprise aprotrusion 182, and the needle driver 164 can comprise a protrusion 184.This arrangement of slots and protrusions can facilitate the transfer ofmotion from the slider component 106 to the respective ones of theneedle component 120 and the plunger 122. Further, the plunger driver162 and the needle driver 164 can comprise rounded bodies that contactand slide against an inner guide surface 198 of the drive component 160when seated within the drive component 160.

FIGS. 4A-4C illustrate the slider component 106 of the inserter 100shown in FIG. 1B, according to sonic embodiments. FIG. 4A illustrates aperspective view of the slider component 106. The slider component 106can comprise a slider body 402 with a proximal end portion 406 and adistal end portion 404. The slider body 402 can have a generallysemi-cylindrical shape. The proximal end portion 406 and the distal endportion 404 can comprise a raised distal boundary or edge 405 and araised proximal boundary or edge 407 that protrude radially from theslider component 106 in order to provide a secure, ergonomic grip with athumb or finger of the operator during use.

The slider component 106 can comprise one or more guide tabs 410. Theguide tabs 410 can be disposed at the distal end portion 404 and theproximal end portion 406. For example, the guide tabs 410 can extendinwardly toward an interior region 412 of the slider component 106. Theinterior region 412 of the slider component 106 can comprise a generallysemi-cylindrical shape or cavity that can be configured to be coupled tothe inserter 100, such as by receiving a portion of the inserter 100therein. When coupled to the inserter 100, the guide tabs 410 can bedisposed within the guide channel 111 of the housing 102 to couple theslider component 106 to the housing 102. Thus, the guide tabs 410 of theslider component 106 can be retained within the guide channel 111,thereby restraining radial movement of the slider component 106 relativeto the housing 102 while allowing for axial or longitudinal movement ofthe slider component 106 along the housing 102, as described herein.

Optionally, the slider component 106 can be configured to include aplurality of guide tabs 410 extending radially inwardly into theinterior region 412 from opposing faces or edges of the slider component106. For example, as illustrated in FIG. 4B, the slider component 106can comprise a pair of guide tabs 410 extending radially inwardly frominterior side edges 414 of the slider component 106. The guide tabs 410can be spaced between about 90 degrees to about 180 degrees apart fromeach other along the interior side edges 414 or an inner surface of theinterior region 412.

Further, in some embodiments, the guide tabs 410 can be beveled to allowthe slider component 106 to be pressed or snapped onto the housing 102and into the guide channel 111. For example, one or more of the guidetabs 410 can comprise a beveled portion facing away from the interiorregion 412. Thus, when the slider component 106 is pressed onto thehousing 102, the slider component 106 can deflect slightly to open theinterior region 412 until the guide tabs 410 snap into place in theguide channels 111.

FIG. 4B illustrates a bottom view of the slider component 106. Referringto FIG. 4B, the protrusion 430 can be formed integrally with the body402 of the slider component 106. However, in accordance with someembodiments, the protrusion 430 can also be formed as a separatecomponent that is later attached to the body 402 of the slider component106. As described herein, the motion of the slider component 106 can betransmitted to the drive assembly 130 via the protrusion 430 and therebyresult in motion of the components of the drive assembly 130 relative tothe housing 102. In some embodiments, the protrusion 430 can be disposedat the proximal end portion 406 of the slider component 106. In someembodiments, the protrusion 430 can be disposed at the distal endportion 404 of the slider component. In some embodiments, the protrusion430 can be disposed in between the proximal end portion 406 and thedistal end portion 404.

FIG. 4C illustrates a top view of the slider component 106. Withreference to FIGS. 4B and 4C, friction tabs 420 can be integrally formedwith the body 402 of the slider component 106. As used herein,“integrally formed” can be defined as being formed as a single,continuous component or piece. Such components can be injection moldedas a single, continuous component or begin as a single part that islater machined or otherwise processed to create various features thatare coupled together from a single, continuous material. For example,through a process such as injection molding or laser beam machining, thefriction tabs 420 can be formed by creating slots 422 that therebydefine shape of the friction tab 420 and allow the friction tab 420 tomove relative to the body 402. The friction tab 420 can be attached tothe body 402, such as by a cantilevered connection or via pivots orattachment points 424. The attachment points 424 can be reinforced orinclude additional body material to improve cycle fatigue strength. Insome embodiments, the friction tabs 420 can be formed as a separatecomponent that are later attached to the body 402 of the slidercomponent 106.

As shown in FIG. 4B, the friction tab 420 can include a biasing memberor friction protrusion 426 which extends radially beyond adjacentportions of the body 402. The protrusion 426 can extend radiallyinwardly toward or into the interior region 412. The protrusion 426 canbe tapered or beveled in shape to allow the slider component 106 totravel over one or more engagement structures, such as the notches,serrations, slots, protrusions, or bumps, of the housing 102 in onedirection and resist direction in an opposite direction.

For example, the protrusion 426 can comprise a deflection-facilitatingdistal surface that extends at an obtuse angle with respect to an innersurface of the slider component 106 and faces the distal boundary oredge 405. As such, in some embodiments, the friction tab 420 can bemoveable or deflectable relative to the body of the slider component106, and the distal surface of the protrusion 426 can permit theprotrusion 426 to begin radial deflection as it slides axially over anengagement structure formed on the housing 102. Such a configuration isillustrated in the side view of FIG. 6A. The distal surface of theprotrusion 426 can therefore be configured to permit or facilitatedistal motion of the slider component 106 along the housing 102.

Further, the protrusion 426 can comprise an anti-reversing proximalsurface that extends perpendicularly from or at an angle (e.g., if aprotrusion, at an acute angle, or if a notch, at an obtuse angle) withrespect to the inner surface of the slider component 106 and faces theproximal boundary or edge 407. The proximal surface of the protrusion426 can therefore be configured to catch or restrict proximal motion ofthe slider component 106 along the housing 102.

In some embodiments, the engagement structure of the housing 102 cancomprise a deflection-facilitating cross-sectional profile, such as arounded shape or angled shape (e.g., extending an obtuse angle from anouter surface 440 of the housing 102) along a proximal-facing portion ofthe engagement structure that initially contacts the protrusion 426 asthe slider component 106 is advanced distally along the housing 102.Further, in some embodiments, both the proximal-facing portion and adistal-facing portion of the engagement structure can comprise adeflection-facilitating cross-sectional profile.

Optionally, the engagement structure of the housing can comprise ananti-reversing cross-sectional profile. For example, the engagementstructure can comprise an edge that extends perpendicularly or at anangle (e.g., if a protrusion, at an obtuse angle, or if a notch, at anacute angle) from the outer surface 440 of the housing 102. In someembodiments, the distal-facing portion of the engagement structure cancomprise the anti-reversing cross-sectional profile. Thus, thedistal-facing portion of the engagement structure can catch with orengage the proximal surface of the protrusion 426 to restrict proximalmotion of the slider component 106 along the housing 102. Additionally,in some embodiments, the proximal-facing portion of the engagementstructure can comprise a deflection-facilitating cross-sectional profileand the distal-facing portion of the engagement structure can comprisean anti-reversing cross-sectional profile.

Optionally, as described further herein, the protrusion 426 and/or theengagement structure can be shaped to provide audible and/or tactilefeedback to the operator. As will be appreciated by personal skill inthe art, a snap or click can be created by deflecting the friction tab420 and quickly permitting release of the friction tab 420 into contactwith the outer surface 440 of the housing 102. This can be accomplishedin a variety of ways, including when the engagement structure includes aperpendicular portion that would permit the protrusion 426 of thefriction tab 420 to rapidly move radially into contact with the outersurface 440 of the housing 102. For example, the distal-facing portionof the engagement structure can extend perpendicularly relative to theouter surface 440 of the housing 102 such that distal advancement of theslider component 106 over the engagement structure permits theprotrusion 426 to snap radially inwardly against the outer surface 440of the housing 102, thereby providing audible and/or tactile feedback tothe operator.

Referring to FIG. 5, an embodiment of an inserter 100 is shown with theslider component 106 attached to the housing 102 by engaging the guidetabs 410 within the guide channels 111. In some embodiments, the guidechannels 111 are disposed on opposite sides of the housing 102. Forexample, the guide tabs 410 and/or the guide channels 111 can beoriented at different angular locations along the slider component 106and/or the housing 102, such at about 180 degrees away from each other,less than 180 degrees away from each other, less than 170 degrees awayfrom each other, less than 160 degrees away from each other, or lessthan 150 degrees away from each other.

When the slider component 106 is engaged in the guide channels 111, theprotrusions 426 can contact portions of the housing 102. For example,the protrusions 426 can contact the housing 102 adjacent to the slot110. In some embodiments, the protrusions 426 can be positioned tocontact the housing 102 on opposing sides of the slot 110.

The protrusions 426 may be biased into contact with the housing 102. Insome embodiments, the protrusions 426 can contact the housing 102 andcause the friction tabs 420 to be urged or deflected radially away fromthe housing 102, e.g., by deforming along the length of the frictiontabs 420 or at the attachment points 424. In some embodiments, body ofthe friction tabs 420 and/or the attachment points 424 can resist thisdeflection or deformation, providing a reaction force via the frictiontabs 420 and the protrusions 426 against the housing 102. In someembodiments, the attachment points 424 and the friction tabs 420 can bebiased to provide a biasing force. This biasing force can urge theslider component 106 radially away from the housing 102, thereby causingthe guide tabs 410 of the slider component 106 to be pressed against theinside of the guide channel 111. Thus, although the guide tabs 410 limitthe radial outward motion of the slider component 106 relative to thehousing 102, the biasing force exerted via the friction tabs 420 canincrease the friction between the slider component 106 and the housing102. Therefore, in some embodiments, the slider component 106 can tendto remain stationary along the housing 102 unless a sufficient axialforce is exerted against the slider component 106 to overcome thefriction between the slider component 106 on the housing 102.

For example, as shown in FIG. 5, as the slider component 106 is forcedradially away from the housing 102, the guide tabs 410 move toward achannel wall 111 a of the guide channel 111. Therefore, in a restingstate the slider component 106 is frictionally retained between theguide tabs 410 and the channel wall 111 a and the protrusions 426 of thefriction tabs 420 against the outer surface of the housing 102.Advantageously, this arrangement also minimizes radial play within theslider component 106 relative to the housing 102.

Additionally, by engaging the friction tabs 420 and the guide tabs 410against the housing 102, the friction force between the slider component106 and the housing 102 is enhanced. This can allow for the slidercomponent 106 to be retained in a desired or initial position, and canprevent inadvertent movement of the slider component 106 during shippingand handling of the inserter 100. Therefore, to move the slidercomponent 106 and thereby operate the inserter, the frictional force ofthe slider component 106 relative to the housing 102 must be overcome bya deliberate, intentional axial force exerted by the operator.

Referring to FIG. 6A, the friction tabs 420 can further provide tactileand audible feedback to the operator during operation of the inserter100. During operation, as the slider component 106 is advanced relativeto the housing 102, the friction tabs 420, and more particularly, thefriction protrusions 426 can pass over engagement structures 103 formedon the housing 102. Each engagement structure 103 can comprise adiscontinuity in an outer surface 440 of the housing 102, such as suchas a notch, serration, slot, protrusion, or bump. The engagementstructures 103 can be indexed to reflect different stages of operationof the inserter 100 or positions of the slider component 106 along thehousing 102 or slot 110. The housing 102 can be configured to includeone or many engagement structures 103. Further, the engagementstructures can be grouped together (as a single group or multiplegroups) or spaced apart along the housing 102.

For example, as shown in FIGS. 6A-6C, the engagement structures 103 canbe configured such that in order for the slider component 106 to moveaway from its initial position, the friction tabs 420 contact against afirst engagement structure 103 a (shown as a group of three engagementstructures 103, although the first engagement structure 103 a can alsocomprise just a single engagement structure 103 or two engagementstructures 103) in the housing 102. Similarly, just before the slidercomponent 106 reaches a certain location long its full travel path(e.g., halfway along the travel path or after the shunt inserter hasexposed the shunt within the eye and just before continued advancementof the slider begins to retract the needle of the inserter back into thehousing), the friction tabs 420 can contact against a second engagementstructure 103 b (shown as a group of three engagement structures 103,although the second engagement structure 103 b can also comprise just asingle engagement structure 103 or two engagement structures 103).Finally, the friction tabs 420 can click against a third engagementstructure 103 c (shown as a group of three engagement structures 103,although the third engagement structure 103 c can also comprise just asingle engagement structure 103 or two engagement structures 103) whenthe slider component 106 has advanced sufficiently to release the shunt.The feedback can be used to signal that the inserter 100 is performing adifferent operation, that the shunt or a portion of the inserter 100 hasreached a certain position, and/or that the different operation canrequire a different actuation force.

Thus, the slider component 106 can move along the housing 102 andprovide tactile and/or audible feedback to the operator regarding aposition of the slider component 106 relative to the housing 102 and/ora position of the shunt or a stage of shunt delivery. In someembodiments, it may be advantageous to provide feedback to the operatorwhen the shunt is initially exposed from the needle of the inserter.Further, it may also be advantageous to provide feedback to the operatorwhen the inserter has released the shunt (which may not yet be fullyexposed outside of the needle).

The type, frequency, and/or strength of tactile and/or audible signalscan vary depending on the position of the slider component 106, theshunt, and/or the state of shunt delivery.

A tactile or audible signal may be provided only when certain milestoneswere achieved, such as initial movement of the slider component, initialshunt exposure of the shunt, a position prior to full release of theshunt (such as when the sleeve has been retracted halfway from its fullyextended position), and/or reaching a final position of the slidercomponent when the shunt is fully released and the needle is fullyretracted (or other such positions, as discussed in U.S. Pat. No.9,585,790, the entirety of which is incorporated herein by reference).Further, some embodiments can be provided in which tactile feedback isprovided only at certain milestones while audible feedback is providedat other milestones. For example, either one of tactile or audiblefeedback can be provided at the beginning stages while the other one oftactile or audible feedback is provided at the latter stages of theprocedure. Further, either one of tactile or audible feedback can beprovided at the beginning and at the end to mark initial and finalslider component movement, while the other one of tactile or audiblefeedback is provided when the shunt is initially exposed and just priorto full release of the shunt. Various options and permutations of theabove can be provided.

Optionally, the housing 102 can comprise a plurality of engagementstructures 103 that provide a continuous, modest tactile or audiblefeedback to the operator to indicate that the slider component 106 isbeing advanced.

Therefore, in accordance with some embodiments, the shape of theengagement structures 103 can be varied along the length of the housing102 to provide varying types, frequencies, and/or strengths of tactileor audible feedback and/or to increase the degree of resistance to theoperator's force required to be exerted to move the slider component.

For example, with regard to the degree of resistance provided by theengagement structures 103, in some embodiments, the engagementstructures 103 can be configured to require the operator to overcome asuccessively higher degree of resistance as the shunt is being exposedand eventually released from the inserter. Thus, the size height oraxial length) of the engagement structures 103 can increase in a distaldirection to thereby create an increasing degree of resistance againstthe distal advancement of the slider component.

The engagement structures 103 can define at least one notch, serration,slot, protrusion, bump, or other modified surface to provide tactileand/or audible signals or feedback to the operator. Referring to FIGS.6A-6C, various features of the engagement structures 103 are shown. Asshown in FIG. 6A, the engagement structure 103 can include one or morenotches, serrations, slots, protrusions, or bumps having an outer orcross-sectional profile 502 that can comprise deflection-facilitatingsurfaces and/or anti-reversing surfaces. The radius 504 and the spacing506 of the engagement structures 103 can be altered. In particular, theradius 504 of the engagement structures 103 can be altered to providestronger feedback or to resist motion of the slider component 106.

As shown in FIG. 6B, the engagement structure 103 can include aperpendicular distal-facing surface 505 that provides a substantial dropfrom the tip or height of the engagement structure 103. In someembodiments, the surface 505 can provide an auditory function as thefriction tab 420 is permitted to ride up the profile 502 on a leading orproximal side and then, the friction tab 420 springs, snaps, or clicksdownwardly or radially inwardly against the housing 102 to provide anaudible and/or tactile signal.

In accordance with some embodiments, the radius or angle of the profile502 or the height of the engagement structure 103 can be modified toprovide a different sound, tactile signal, or to increase slidingresistance against the slider component 106 as the slider component 106is across the engagement structure 103.

Optionally, when the engagement structures 103 are grouped together, thespacing between the engagement structures 103 can be altered to changethe frequency of occurrence of the audible signals from the auditorymechanism of the friction tab 420.

As shown in FIG. 6C, the engagement structures 103 can comprise across-sectional profile 502 having tapered peaks. The tapered peaks mayprovide a different audible and/or tactile feedback compared to thefeatures of the bumps or serrated structures shown in FIGS. 6A and 6B.Similar to the structures illustrated in FIGS. 6A and 6B, the height andthe spacing of the tapered peaks can be altered to provide a desiredaudible or tactile signal.

In some embodiments, different engagement structures 103 can utilizedifferent features to provide different signals to an operator. In someembodiments, a single engagement structure 103 can utilize a combinationof the features described in FIGS. 6A-6C,

As illustrated, FIG. 7A is a perspective view of a sleeve mount 144coupled to a straight sleeve component 124, as also shown and discussedabove in the embodiment of FIG. 2. However, the sleeve component canalso be configured to comprise a bend, as illustrated in FIG. 7B, FIG.7B illustrates a sleeve component 124 a that has a slight curve or bend290. The bend 290 can be adjacent to the sleeve mount 144 and provide anangular deviation 292 of an axis 293 of the sleeve component 124 a fromthe longitudinal axis 178 within a range of between about 3 degrees toabout 30 degrees, between about 4 degrees to about 15 degrees, betweenabout 5 degrees to about 13 degrees, or of about 8 degrees relative tothe longitudinal axis of the inserter 100.

The bend in the sleeve component 124 a can improve the accessibility toareas of the eye, such as when the inserter approaches the eye from aposition in which the inserter is positioned above the cheekbone.

Additionally, as illustrated, an insertion or distal end portion 294 ofthe sleeve component 124 a can be substantially straight while adeployment or proximal end portion 296 of the sleeve component 124 a cancomprise a curve or bend. Further, in some embodiments, the distal endportion 294 and the proximal end portion 296 can both comprise a bend orbe straight with a bend section disposed therebetween. The proximal endportion 296 can be about a quarter to about a half of the overall lengthof the sleeve component 124 a. In some embodiments, the length of theproximal end portion 296 can be about one third of the length of thesleeve component 124 a. Accordingly, in some embodiments, the distal endportion 294 can be about a half to about three quarters of the length ofthe sleeve component 124 a, and in some embodiments, about two thirds ofthe length of the sleeve component 124 a, Advantageously then, thedistal end portion 294 of the sleeve component 124 a can be of asufficient length such that the entirety of the sleeve component 124 athat enters the eye is substantially straight.

While the sleeve component 124 a can comprise a rigid structure that canwithstand typical bending stresses in performing embodiments of theprocedures disclosed herein, the needle component 120 can be made from aflexible shaft that can deflect during proximal withdrawal of the needlecomponent 120 into the sleeve component 124 a.

Thus, a proximal portion of the needle component 120 that extends alongthe bend 290 of the sleeve component 124 a can be proximally withdrawninto the sleeve component 124 a proximal or adjacent to the sleeve mount144. After such motion, although the proximal portion of the needlecomponent 120 was bended, that same portion of the needle component 120can flex and straighten out as the needle component 120 is pulledproximally into a straight portion of the needle component 120 or othercomponents within the inserter. Additionally, portions of the needlecomponent 120 that reside in the distal end portion of the sleevecomponent 124 a (and are therefore in a straight configuration) can beflexed or deflected into a curved or betided configuration when theneedle component 120 is proximally retracted through the bend 290 of thesleeve component 124 a.

Accordingly, the use of an arcuate or bent sleeve component 124 a incombination with a flexible or conforming needle component 120 can allowsome embodiments of the inserter to provide improved accessibility toareas of the eye.

Some embodiments can implement aspects of the sleeve structures andmethods of use disclosed in applicant's U.S. Patent Application Publ.No. 2012/0123434, the entirety of which is incorporated herein byreference.

Referring to FIG. 8A-10A, in some embodiments, it may be desirable thatthe shaft or needle component 120 comprise a bend for sonic of thereasons discussed herein. In some embodiments, the bend can be betweenabout 1 degree and about 20 degrees, about 2 degrees and about 18degrees, about 3 degrees and about 16 degrees, about 4 degrees and about14 degrees, about 3 degrees and about 16 degrees, about 5 degrees andabout 12 degrees, about 6 degrees and about 10 degrees, or about 1degrees, about 2 degrees, about 3 degrees, about 4 degrees, about 5degrees, about 6 degrees, about 7 degrees, about 8 degrees, about 9degrees, about 10 degrees, about 11 degrees, about 12 degrees, about 13degrees, about 14 degrees, about 15 degrees, about 16 degrees, about 17degrees, about 18 degrees, about 19 degrees, or about 20 degrees.

Optionally, in some embodiments, the needle component 129 can be held ina bended configuration. In accordance with some embodiments, the sleevecomponent 124 can be straight and/or selectively angled or bent with theuse of a removable or retrofittable end component, deflector component,or alignment guide 602. In some embodiments, an inserter 100 can bedelivered with an alignment guide 602 coupled to the inserter 100 ordisposed over the sleeve component 124.

Referring to FIG. 8A, the alignment guide 602 can comprise a hollowguide shaft 603 that is coupled to an attachment portion 604. Theattachment portion 604 can be keyed or indexed in order to rotationallyorient the alignment guide 602 relative to the housing 102 of theinserter 100. For example, the attachment portion 604 can serve tocouple the alignment guide 602 to the housing 102 in a desired angularor rotational orientation in order to set a bend direction and/or of theneedle relative to the longitudinal axis of the housing 102 of theinserter 100.

In some embodiments, the hollow guide shaft 603 can be disposed overportions of the sleeve component 124 and the needle component 120. Theguide shaft 603 can have an angle similar to or determine the angle ofthe angled sleeve component described herein. For example, the alignmentguide 602 can bend the sleeve component 124 and the needle component 120at a bend 690 and provide an angular deviation 692 of an axis 693 of theguide shaft 603 from a longitudinal axis 178 of the inserter 100 withina range of between about 0 degrees and about 30 degrees, between about 0degrees and about 20 degrees, between about 0 degrees and about 15degrees, or at about 8 degrees relative to the longitudinal axis of theinserter.

Thus, in some embodiments, an operator can modify a needle of aninserter by applying the alignment guide to the inserter, therebybending the needle to a desired angular orientation. The alignment guidecan be provided as part of a set of alignment guides that have differentangular orientations. The alignment guide can be retrofittable to anyexisting inserter. Further, the alignment guide can be configured tomate with distal end portion of inserter in order to securely engage thealignment guide rotationally and longitudinally relative to theinserter.

For example, in some embodiments, the operator can rotate the needleuntil the bevel begins to push the conjunctiva away from the sclera, asdiscussed and shown in U.S. Pat. No. 9,585,790, the entirety of which isincorporated herein by reference. This procedure, which can be referredto as “tenting” the conjunctiva, can create a small space or gap betweenthe conjunctiva and the sclera adjacent to the bevel of the needle. Oncea space has been created by tenting the conjunctive, a shunt can beadvanced into the space from the needle. As a result, the shunt can besubstantially easier to push into the space because the conjunctiva hasbeen pushed away and is not immediately obstructing the advancement ofthe shunt into the subconjunctival space.

Additionally, in some embodiments, an insertion or distal end portion694 of the guide shaft 603 can be substantially straight while adeployment or proximal end portion 696 of the guide shaft 603 cancomprise a curve or bend. Further, in some embodiments, the distal endportion 694 and the proximal end portion 696 can both comprise a bend orbe straight with a bend section disposed therebetween. The proximal endportion 696 can be about one quarter to about one half of the overalllength of the guide shaft 603. In some embodiments, the length of theproximal end portion 696 can be about one third of the length of theguide shaft 603. Accordingly, in some embodiments, the distal endportion 694 can be about one half to about three quarters of the lengthof the guide shaft 603, and in some embodiments, about two thirds of thelength of the guide shaft 603.

The alignment guide 602 can allow an operator to modify the angle of thesleeve component 124 and the needle component 120 prior to a procedure(e.g., by permitting the operator to select from a variety of differentalignment guides having different angular orientations andconfigurations of relative lengths of the proximal and distal endportions) without having to replace the needle component 120 of theinserter 100. Further, the guide shaft 603 can provide enhancedstiffness to the sleeve component 124 and the needle component 120. Insome embodiments, the alignment guide 602 can facilitate the use ofthinner gauge needles for the needle component 120, including, but notlimited to needles of 28 Gauge or thinner in size. Thus, implementationsof the present disclosure can advantageously allow very small, delicateneedles to be used in the delivery of an intraocular shunt whileensuring that the needle exhibits sufficient strength and stiffnessduring the delivery process.

The sleeve component 124 and the needle component 120 can be flexible orelastic to allow deflection when the alignment guide 602 is installed.The alignment guide 602 can be removed to allow the sleeve component 124and the underlying needle component 120 to move to a default straightconfiguration. For example, the alignment guide 602 can be configured toelastically deform the sleeve component 124. Thus, upon removal of thealignment guide 602, the sleeve component 124 and the needle component120 will return to a straight configuration. Further, the alignmentguide 602 can be reinstalled on the housing 102, if needed.

As shown in FIGS. 8A-8C, in some embodiments, proper rotationalalignment of the alignment guide 602 can be facilitated by theattachment portion 604, which can be keyed or indexed, that orients thealignment guide 602 relative to the housing 102. The index grooves 605of the attachment portion 604 can align with the index protrusions 105of the housing 102. In some embodiments, the index grooves 605 can bekeyed to the index protrusions 105 to allow the alignment guide 602 toattach to the housing 102 in a desired orientation. Thus, the alignmentguide 602 and the inserter 100 can be configured to have one or morepreset relative orientations. The index grooves 605 can be in the shapeof longitudinally extending indentations or slots formed in theattachment portion 604.

Further, the index grooves 605 can be spaced apart from each other(e.g., circumferentially) at equal circumferential distances, and theindex protrusions 105 can be spaced apart from each other (e.g.,circumferentially) at equal circumferential spacings, so that thealignment guide 602 can be rotated to one or more preset rotationalorientations. However, the circumferential distances between the indexgrooves 605 and/or the index protrusions 105 can vary. In the embodimentillustrated in FIGS. 8A-8C, there are four preset rotationalorientations. In some embodiments, the alignment guide 602 can comprisea single index groove 605 that can be mated with a single indexprotrusion 105 of the housing 102 so that the alignment guide 602 has asingle rotational orientation relative to the inserter 100.

The attachment portion 604 can have a number of index grooves 605 thatis the same in number as the index protrusions 105. However, in someembodiments, the alignment guide 602 can comprise more index grooves 605than there are index protrusions 105. For example, although there can befour index protrusions 105 and four index grooves 605, there can be fourindex protrusions 105 and eight index grooves 605, four indexprotrusions 105 and twelve index grooves 605, or ratios of indexprotrusions 105 to index grooves 605 of 1:4, 1:5, 1:6, or more.

FIG. 9A is a front perspective view of another retrofittable endcomponent, deflector component, or alignment guide 700, according tosome embodiments. Similar to the alignment guide 602 shown in FIGS.8A-8C, the alignment guide 700 can be used to bend or maintain thesleeve component 124 in a straight and/or selectively angled or bentconfiguration. Certain details or usage of the alignment guide 602 canalso be implemented with the alignment guide 700, as discussed herein,and will not be repeated here for brevity.

As shown in FIGS. 9A and 9B. The alignment guide 700 can comprise aguide shaft 702 that is coupled to an attachment portion 704. Similar tothe alignment guide 602, the attachment portion 704 can comprise one ormore index grooves 706 that facilitate alignment and/or coupling of thealignment guide 700 relative to the housing 102 of the inserter 100.

As with the alignment guide 602 discussed above, the inserter 100 can bedelivered with the alignment guide 700 coupled to the inserter 100 ordisposed over the sleeve component 124. In some embodiments, the hollowguide shaft 702 can be disposed over portions of the sleeve component124 and the needle component 120. The guide shaft 702 can have an anglesimilar to or determine the angle of the angled sleeve componentdescribed herein. The alignment guide 700 can bend the sleeve component124 and the needle component 120 and provide an angular deviation 710 ofan axis 712 of the guide shaft 702 from a longitudinal axis 178 of theinserter 100 within a range of between about 0 degrees and about 30degrees, between about 0 degrees and about 20 degrees, between about 0degrees and about 15 degrees, or at about 8 degrees relative to thelongitudinal axis of the inserter.

Additionally, similar to the alignment guide 602, an insertion or distalend portion 720 of the guide shaft 702 can be substantially straightwhile a deployment or proximal end portion 722 of the guide shaft 702can comprise a curve or bend. Further, in some embodiments, the distalend portion 720 and the proximal end portion 722 can both comprise abend or be straight with a bend section disposed therebetween. Theproximal end portion 722 can be about one quarter to about one half ofthe overall length of the guide shaft 702. In some embodiments, thelength of the proximal end portion 722 can be about one third of thelength of the guide shaft 702. Accordingly, in some embodiments, thedistal end portion 720 can be about one half to about three quarters ofthe length of the guide shaft 702, and in some embodiments, about twothirds of the length of the guide shaft 702.

Similar to the alignment guide 602, the alignment guide 700 can allow anoperator to modify the angle of the sleeve component 124 and the needlecomponent 120 prior to a procedure (e.g., by permitting the operator toselect from a variety of different alignment guides having differentangular orientations and configurations of relative lengths of theproximal and distal end portions) without having to replace the needlecomponent 120 of the inserter 100. Further, the guide shaft 702 canprovide enhanced stiffness to the sleeve component 124 and the needlecomponent 120. In some embodiments, the alignment guide 700 canfacilitate the use of thinner gauge needles for the needle component120, including, but not limited to needles of 28 Gauge or thinner insize. Thus, implementations of the present disclosure can advantageouslyallow very small, delicate needles to be used in the delivery of anintraocular shunt while ensuring that the needle exhibits sufficientstrength and stiffness during the delivery process.

As also similarly noted above, the sleeve component 124 and the needlecomponent 120 can be flexible or elastic to allow deflection when thealignment guide 700 is installed. The alignment guide 700 can be removedto allow the sleeve component 124 and the underlying needle component120 to move to a default straight configuration. For example, thealignment guide 700 can be configured to elastically deform the sleevecomponent 124. Thus, upon removal of the alignment guide 700, the sleevecomponent 124 and the needle component 120 will return to a straightconfiguration. Further, the alignment guide 700 can be reinstalled onthe housing 102, if needed.

As noted similarly above with respect to FIGS. 8A-8C, the alignmentguide 700 of FIGS. 9A and 9B can be properly rotationally alignedrelative to the inserter 100 by the attachment portion 704, which can bekeyed or indexed, that orients the alignment guide 700 relative to thehousing 102. The index grooves 706 of the attachment portion 704 canalign with the index protrusions 105 of the housing 102. In someembodiments, the index grooves 706 can be keyed to the index protrusions105 to allow the alignment guide 700 to attach to the housing 102 in adesired orientation. Thus, the alignment guide 700 and the inserter 100can be configured to have one or more preset relative orientations. Theindex grooves 706 can be in the shape of longitudinally extendingindentations or slots formed in the attachment portion 704.

Further, the index grooves 706 can be spaced apart from each other(e.g., circumferentially) at equal circumferential distances, and theindex protrusions 105 can be spaced apart from each other (e.g.,circumferentially) at equal circumferential spacings, so that thealignment guide 700 can be rotated to one or more preset rotationalorientations. However, the circumferential distances between the indexgrooves 706 and/or the index protrusions 105 can vary. In the embodimentillustrated in FIGS. 9A and 9B, there are four preset rotationalorientations. In some embodiments, the alignment guide 700 can comprisea single index groove 706 that can be mated with a single indexprotrusion 105 of the housing 102 so that the alignment guide 700 has asingle rotational orientation relative to the inserter 100.

The attachment portion 704 can have a number of index grooves 706 thatis the same in number as the index protrusions 105. However, in someembodiments, the alignment guide 700 can comprise more index grooves 706than there are index protrusions 105. For example, although there can befour index protrusions 105 and four index grooves 706, there can be fourindex protrusions 105 and eight index grooves 706, four indexprotrusions 105 and twelve index grooves 706, or ratios of indexprotrusions 105 to index grooves 706 of 1:4, 1:5, 1:6, or more.

In accordance with some embodiments, the attachment portion 704 of thealignment guide 700 can comprise one or more retention or engagementfeatures that enable the alignment guide to snap onto or otherwiseengage with corresponding engagement features of the distal end portionof the inserter 100. Such features can also be used in conjunction withthe attachment portion 604 of the alignment guide 602.

In accordance with some embodiments, various components can be used toprotect the needle component of the inserter. These components can beused individually or in combination with each other to reposition and/orprotect the needle component, such as the bevel of the needle component,from being damaged during transport or shipping of the inserter or theneedle assembly. Such components that can be used for this purposeinclude the alignment guide 602 or 700, a protective cap, and a bevelprotection device. These components and examples of their combined usesare discussed below with regard to FIGS. 10A and 10B.

As shown in FIGS. 10A and 10B, in some embodiments, a bevel protectiondevice 820 can be inserted into the needle component 120 in order toprotect a bevel area or bevel 800 of the needle component 120. Asillustrated in FIG. 10A, in some embodiments, the alignment guide 602(which can also be the alignment guide 700) can be coupled to theinserter 100 and used to angle the sleeve component 124 and/or needlecomponent 120 to protect the sleeve component 124 and/or needlecomponent 120 by keeping the sleeve component 124 angled towards theprotective cap 610 while the bevel protection device 820 is insertedinto the needle component 120. Thus, as illustrated, the bevelprotection device 820 can extend distally from the needle component 120and contact the inner sidewall of the protective cap 610. Therefore,with the alignment guide 602 bending the needle component 120 in adirection away from the central axis of the protective cap 610 (ortoward a sidewall of the protective cap 610), the bevel protectiondevice 820 can be configured to contact the sidewall of the protectivecap 610, thus spacing the bevel 800 of the needle component 120 awayfrom and avoiding contact with the sidewall of the protective cap 610.

Additionally, the protective cap 610 configured to engage with a portionof the housing 102 in order to secure the protective cap 610 onto adistal portion of the housing 102 in order to cover and protect thesleeve component 124 and the needle component 120.

As noted above, in accordance with some embodiments, the bevelprotection device 820 can also be used to reduce or prevent inadvertentcontact of the bevel 800 of the needle component with other structures,such as the protective cap 610, during transport and shipping of theinserter or the needle assembly. When used in combination with thealignment guide 602 or 700, the alignment guide 602 or 700 can cause adesired contact between the bevel protection device 820 and theprotective cap 610 to position the needle component 120 in a protectedposition. However, in some embodiments, the bevel protection device 820can be used with by itself or with either or both of the protective cap610 or the alignment guide 602 or 700.

The inserter 100 can be used in combination with a bevel protectiondevice that engages with a needle component 120 of the inserter 100 inorder to prevent accidental damage to the bevel 800 of the needlecomponent 120. In some embodiments, the bevel protection devicedescribed herein can be used with the angled sleeve component 124 and/orthe alignment guide 602 or 700 to dispose an end of the protectiondevice against the protective cap 610.

For example, FIG. 10B illustrates a distal end portion of a needlecomponent 120 of an inserter. The bevel protection device 820 can engagewith a distal end portion 822 of the needle component 120. The bevelprotection device 820 can comprise an elongate body 824 that comprises afirst portion 826 and a second portion 828. The first portion 826 cantaper from a larger diameter cross-section to a smaller diametercross-section. The smaller diameter cross-section can be less than aninner diameter of the distal end portion 822 of the needle component120. Thus, the first portion 826 can be inserted into a lumen 830 of theneedle component 120.

The elongate body 824 can be configured such that the tapering of thefirst portion 826 provides the elongate body 824 with a variablediameter cross-section. The diameter can taper gradually or in steps.

As shown in the embodiment illustrated in FIG. 10B, the cross-sectionalprofile or diameter of the elongate body 824 adjacent to the secondportion 828 can be greater than the cross-sectional profile or diameterof the elongate body 824 near the first portion 826. For example, fromthe first portion 826 toward the second portion 828, the cross-sectionaldiameter of the elongate body 824 can increase from a diameter that isless than an inner diameter of the lumen 830 of the needle component 120to a diameter that is greater than the inner diameter of the lumen 830.Thus, the elongate body 824 can be inserted into the lumen 830 of theneedle component 120 and advanced to a position at which thecross-section of the elongate body is about equal to the inner diameterof the lumen 830, thus restricting further advancement of the bevelprotection device 820 into the lumen 830.

In some embodiments, the elongate body 824 can frictionally engage withthe distal end portion 822 of the needle component 120. For example, theretention device 820 can be force fit into the needle component 120 tocreate a frictional engagement between the outer surface of the elongatebody 824 and an inner surface of the lumen 830. This frictionalengagement can be overcome by exerting a withdrawal force on the secondportion 828 of the retention device 820, thereby pulling the bevelprotection device 820 out of the lumen 830.

Although the bevel protection device 820 is illustrated as having acircular or diametrical cross section, other cross sections can also beused, such as triangular, square, rectangular, polygonal, star-shaped,or other similar profiles. Further, the bevel protection device 820 canbe made of steel. In accordance with some embodiments, the bevelprotection device 820 may only contact the inside of the needle bevel800, and therefore advantageously does not affect the needle sharpness,which is driven by the needle outside edges.

The bevel protection device 820 can therefore ensure that the edges ofthe bevel 800 of the needle to not come into contact with other surfacesto prevent damage during shipment or initial handling of the inserter orneedle assembly. When the operator is prepared to use in inserter, thebevel protection device 820 can be withdrawn from the needle component120 and the procedure can be carried out.

Further, in some embodiments, the inserter 100 can comprise tactile oraudible feedback mechanisms that do not require or generate consistentor persistent frictional engagement against the housing 102. Thus,features of the inserter discussed herein can be incorporated into someembodiments while excluding other features discussed herein.

Although the detailed description contains many specifics, these shouldnot be construed as limiting the scope of the subject technology butmerely as illustrating different examples and aspects of the subjecttechnology. It should be appreciated that the scope of the subjecttechnology includes other embodiments not discussed in detail above.Various other modifications, changes and variations may be made in thearrangement, operation and details of the method and apparatus of thesubject technology disclosed herein without departing from the scope ofthe present disclosure. Unless otherwise expressed, reference to anelement in the singular is not intended to mean “one and only one”unless explicitly stated, but rather is meant to lean “one or more.” Inaddition, it is not necessary for a device or method to address everyproblem that is solvable by different embodiments of the disclosure inorder to be encompassed within the scope of the disclosure.

Illustration of Subject Technology as Clauses

Various examples of aspects of the disclosure are described below asclauses for convenience. These are provided as examples, and do notlimit the subject technology.

Clause 1. An intraocular shunt inserter for treating glaucoma,comprising: a housing having a distal portion, a proximal portion, alongitudinal axis extending between the distal and proximal portions,the housing further comprising an inner cavity, a guide channel and anelongate slot, the guide channel extending along the longitudinal axisand accessible along an outer surface of the housing, the guide channelhaving an inner wall, the elongate slot extending along the longitudinalaxis along the outer surface of the housing into the inner cavity; and aslider component slidably coupled to the housing along the outer surfacethereof, the slider component slidable along the elongate slot foractuating a function of the inserter via the elongate slot, the slidercomponent comprising a guide tab and a friction tab, the guide tabdisposed within and slidable along the guide channel of the housing, thefriction tab being movable relative to the guide tab and comprising abiasing portion configured to urge the friction tab against the housingfor causing the guide tab to be contacted against the inner wall of theguide channel for providing frictional resistance between the slidercomponent and the housing against sliding.

Clause 2. The inserter of Clause 1, wherein the slider componentcomprises an interior region into which the housing is fitted.

Clause 3. The inserter of Clause 2, wherein the interior region issemi-cylindrical.

Clause 4. The inserter of any of Clauses 2 to 3, wherein the frictiontab extends inwardly toward the interior region of the slider componentfor contacting an outer surface of the housing.

Clause 5. The inserter of Clause 4, wherein the friction tab comprises apair of friction tabs extending inwardly toward the interior region ofthe slider component.

Clause 6. The inserter of any of Clauses 2 to 5, wherein the guide tabextends inwardly toward the interior region of the slider component.

Clause 7. The inserter of any of Clauses 2 to 6, wherein the guide tabcomprises a pair of guide tabs extending inwardly toward the interiorregion of the slider component.

Clause 8. The inserter of any of Clauses 2 to 8, wherein the slidercomponent comprises a generally cylindrical profile and the guide tabsare spaced between about 90 degrees to about 180 degrees apart from eachother along an inner surface of the interior region.

Clause 9. The inserter of any of the preceding Clauses, wherein whencoupled to the housing, the slider component contacts the housing onlyvia the guide tab and the friction tab.

Clause 10. The inserter of any of the preceding Clauses, wherein theguide tab comprises a pair of guide tabs, each of the pair of guide tabscomprising a longitudinally extending flange configured to sit withinthe guide channel.

Clause 11. The inserter of any of the preceding Clauses, wherein thehousing comprises a generally cylindrical profile and a pair of guidechannels are spaced between about 90 degrees to about 180 degrees apartfrom each other along the outer surface of the housing.

Clause 12. The inserter of Clause 11, wherein the guide channels aredisposed about 180 degrees from each other.

Clause 13. The inserter of any of the preceding Clauses, wherein theguide tab, the friction tab, and the slider component are formed as asingle, continuous piece of material.

Clause 14. The inserter of any of the preceding Clauses, wherein thefriction tab is formed as a cut out through a body of the slidercomponent.

Clause 15. The inserter of Clause 14, wherein the friction tab comprisesa protrusion extending toward an interior region of the slidercomponent.

Clause 16. The inserter of Clause 15, wherein when the slider componentis coupled to the housing, the protrusion of the friction tab contactsthe housing.

Clause 17. The inserter of Clause 16, wherein the protrusion of thefriction tab contacts the housing to cause the friction tab to bend in adirection away from the guide tab.

Clause 18. The inserter of any of the preceding Clauses, wherein thehousing comprises a generally cylindrical profile.

Clause 19. The inserter of any of the preceding Clauses, wherein thehousing comprises an engagement structure against which the friction tabcan contact the housing for providing audible or tactile feedback to anoperator.

Clause 20. The inserter of Clause 19, wherein the engagement structurecomprises at least one discontinuity in the outer surface of thehousing.

Clause 21. The inserter of Clause 19, wherein the engagement structurecomprises at least one bump on the outer surface of the housing.

Clause 22. The inserter of Clause 19, wherein the engagement structurecomprises a plurality of serrated features on the outer surface of thehousing.

Clause 23. The inserter of Clause 19, wherein the engagement structurecomprises a plurality of tapered peaks on the outer surface of thehousing.

Clause 24. The inserter of Clause 19, wherein the function of theinserter comprises advancing a shunt within a needle, and a position ofthe slider component along the engagement structure corresponds to adeployment position of the shunt relative to the needle.

Clause 25. The inserter of Clause 19, wherein the engagement structurecomprises a plurality of bumps on the outer surface of the housing,wherein each of the bumps corresponds to a deployment position of anintraocular shunt.

Clause 26. The inserter of any of the preceding Clauses, wherein theslider component is operatively coupled to a deployment mechanism withinthe housing.

Clause 27. The inserter of Clause 26, wherein the slider component iscoupled to the deployment mechanism via a rod extending through theelongate slot, the rod being coupled to the slider component and thedeployment mechanism.

Clause 28. The inserter of any of the preceding Clauses, furthercomprising a hollow needle that comprises a bend at an angle of betweenabout 6 degrees to about 10 degrees, the needle being configured tocarry an intraocular shunt.

Clause 29. The inserter of Clause 28, wherein the needle defines astraight section and an angled section.

Clause 30. The inserter of any of the preceding Clauses, furthercomprising a hollow needle extending from a distal end portion of theinserter, the inserter further comprising a deflector componentreleasably attachable to the distal end portion of the inserter, andwherein when the deflector component is coupled to the inserter, thehollow needle extends through the deflector component and the deflectormaintains the needle in a bended configuration.

Clause 31. The inserter of Clause 30, wherein in the bendedconfiguration, the needle is bended at an angle of between about 6degrees to about 10 degrees.

Clause 32. The inserter of Clause 30, wherein when coupled with thedeflector, the needle is elastically deformed.

Clause 33. The inserter of Clause 30, wherein the distal end portion ofthe inserter comprises an indexing structure and the deflector componentcomprises an alignment index, wherein the alignment index of thedeflector component can be releasably engaged with the indexingstructure to define a rotational orientation of the deflector componentrelative to the inserter.

Clause 34. The inserter of Clause 33, wherein the deflector componentcomprises a bent needle guide attached to and extending from a coupler,wherein the alignment index is formed along the coupler.

Clause 35. The inserter of Clause 34, wherein the alignment index ispositioned along a proximal portion of the coupler.

Clause 36. The inserter of Clause 34, wherein the alignment indexcomprises at least one groove extending along a perimeter of thecoupler.

Clause 37. The inserter of Clause 34, wherein the needle guide comprisesa hollow shaft.

Clause 38. The inserter of Clause 33, wherein the indexing structurecomprises at least one protrusion configured to slide into acorresponding groove.

Clause 39. An intraocular shunt inserter for treating glaucoma,comprising: a housing having a distal portion, a proximal portion, and alongitudinal axis extending between the distal and proximal portions,the housing further comprising an interior cavity, a guide channel, andan elongate slot extending along an outer surface of the housing intothe cavity for actuating a function of the inserter; and a slidercomponent coupled to the housing and positioned along the outer surfacethereof, the slider component slidable along the elongate slot, theslider comprising a guide tab disposed within the guide channel; and aposition feedback mechanism comprising a biased tab and an engagementstructure, the biased tab being coupled to the slider component, theengagement structure being formed along the outer surface of thehousing, wherein motion of the slider component causes the biased tab toslide along the engagement structure to generate tactile or audiblefeedback to an operator regarding a position of an intraocular shuntrelative to the inserter.

Clause 40. The inserter of Clause 39, wherein the engagement structurecomprises at least one discontinuity in the outer surface of thehousing.

Clause 41. The inserter of any of Clauses 39 to 40, wherein theengagement structure comprises at least one bump on the outer surface ofthe housing.

Clause 42. The inserter of any of Clauses 39 to 41, wherein theengagement structure comprises a plurality of serrated features on theouter surface of the housing.

Clause 43. The inserter of any of Clauses 39 to 42, wherein theengagement structure comprises a plurality of tapered peaks on the outersurface of the housing.

Clause 44. The inserter of any of Clauses 39 to 43, wherein the functionof the inserter comprises advancing a shunt within a needle, and aposition of the slider component along the engagement structurecorresponds to a deployment position of the shunt relative to theneedle.

Clause 45. The inserter of any of Clauses 39 to 44, wherein theengagement structure comprises a plurality of bumps on the outer surfaceof the housing, wherein each of the bumps corresponds to a deploymentposition of an intraocular shunt.

Clause 46. The inserter of Clause 45, wherein each of the plurality ofbumps is disposed along the housing at positions corresponding torotational positions of a drive component of a deployment mechanism ofthe inserter.

Clause 47. The inserter of any of Clauses 39 to 46, further comprising ahollow needle extending from a distal end portion of the inserter, theinserter further comprising a deflector component releasably attachableto the distal end portion of the inserter, and wherein when thedeflector component is coupled to the inserter, the hollow needleextends through the deflector component and the deflector maintains theneedle in a bended configuration.

Clause 48. The inserter of Clause 47, wherein in the bendedconfiguration, the needle is bended at an angle of between about 6degrees to about 10 degrees.

Clause 49. The inserter of Clause 47, wherein when coupled with thedeflector, the needle is elastically deformed.

Clause 50. The inserter of Clause 52, wherein the needle guide comprisesa hollow shaft.

Clause 51. The inserter of Clause 47, wherein the distal end portion ofthe inserter comprises an indexing structure and the deflector componentcomprises an alignment index, wherein the alignment index of thedeflector component can be releasably engaged with the indexingstructure to define a rotational orientation of the deflector componentrelative to the inserter.

Clause 52. The inserter of Clause 51, wherein the deflector componentcomprises a bent needle guide attached to and extending from a coupler,wherein the alignment index is formed along the coupler.

Clause 53. The inserter of Clause 52, wherein the alignment index ispositioned along a proximal portion of the coupler.

Clause 54. The inserter of Clause 52, wherein the alignment indexcomprises at least one groove extending along a perimeter of thecoupler.

Clause 55. The inserter of Clause 54, wherein the indexing structurecomprises at least one protrusion configured to slide into the at leastone groove.

Clause 56. The inserter of Clause 47, wherein the needle is elasticallydeformable.

Clause 57. A method of operating an intraocular shunt inserter, themethod comprising: distally advancing a slider component along a housingof an intraocular shunt inserter by overcoming a frictional resistancebetween a friction tab of the slider component and the housing, theslider component being slidable for actuating a function of theinserter, the slider component comprising a guide tab and a frictiontab, the guide tab disposed within and slidable along a guide channel ofthe housing, the friction tab being movable relative to the guide taband comprising a biasing portion configured to urge the friction tabagainst the housing for causing the guide tab to be contacted against aninner wall of the guide channel for providing the frictional resistancebetween the slider component and the housing; and contacting a plunger,engaged with the slider, against a shunt disposed within a needle of theinserter to distally advance the shunt within the needle.

Clause 58. The method of Clause 57, further comprising engaging adiscontinuity of the housing via the friction tab.

Clause 59. The method of Clause 58, further comprising generating anaudible signal by engaging the discontinuity.

Clause 60. The method of any of Clauses 58 to 59, wherein a position ofthe discontinuity corresponds to a position of the shunt within a lumenof the needle.

Clause 61. The method of Clause 60, wherein the discontinuity comprisesa bump.

Clause 62. The method of Clause 60, wherein the discontinuity comprisesa serrated feature.

Clause 63. The method of Clause 60, wherein the discontinuity comprisesa tapered peak.

Clause 64. The method of any of Clauses 57 to 63, further comprisingbending the needle of the inserter by coupling a deflector component toa distal end portion of the inserter.

Clause 65. The method of Clause 64, wherein the bending comprisesinserting the needle through the deflector component to cause the needleto bend.

Clause 66. The method of Clause 64, wherein the bending comprisesbending the needle at an angle of between about 6 degrees to about 10degrees.

Clause 67. The method of Clause 64, wherein the deflector componentdefines a straight insertion portion and an angled deployment portion.

Clause 68. The method of Clause 64, further comprising aligning thedeflector component with the distal end portion of the inserter via anindexing mechanism.

Clause 69. The method of Clause 68, wherein the indexing mechanismcomprises at least one protrusion on the distal end portion of theinserter.

Clause 70. The method of any of Clauses 57 to 69, further comprisingelastically deforming the needle.

Clause 71. A system for deploying an intraocular shunt, the systemcomprising: an intraocular shunt inserter comprising a housing having adistal end portion and a needle extending from the distal end portion;and a deflector component releasably attachable to the distal endportion of the inserter, the deflector component having a needle guideconfigured to receive the needle of the inserter therein, wherein theneedle guide maintains the needle in a bended configuration.

Clause 72. The system of Clause 71, wherein the needle guide comprises ahollow shaft.

Clause 73. The system of any of Clauses 71 to 72, wherein in the healedconfiguration, the needle is bended at an angle of between about 6degrees to about 10 degrees.

Clause 74. The system of any of Clauses 71 to 73, wherein when coupledwith the deflector component, the needle is elastically deformed.

Clause 75. The system of any of Clauses 71 to 74, wherein the distal endportion of the inserter comprises an indexing structure and thedeflector component comprises an alignment index, wherein the alignmentindex of the deflector component can be releasably engaged with theindexing structure to define a rotational orientation of the deflectorcomponent relative to the inserter.

Clause 76. The system of Clause 75, wherein the deflector componentcomprises a coupler, the needle guide being attached to the coupler,wherein the alignment index is formed along the coupler.

Clause 77. The system of Clause 76, wherein the alignment index ispositioned along a proximal portion of the coupler.

Clause 78. The system of Clause 76, wherein the alignment indexcomprises at least one groove extending along a perimeter of thecoupler.

Clause 79. The system of Clause 76, wherein the indexing structurecomprises at least one protrusion configured to slide into acorresponding groove.

Clause 80. An intraocular shunt delivery device, comprising: acylindrical housing comprising guide channels extending longitudinallyalong the housing, each guide channel defining an inner wall having anupper face; and a semi-cylindrical slider disposed about the housing,wherein the slider is axially moveable relative to the housing, theslider comprising: a pair of guide tabs disposed within respective onesof the guide channels of the housing to secure the slider to thehousing; a friction tab, disposed intermediate the guide tabs on theslider, comprising a biasing portion configured to urge the friction tabagainst the housing for causing the guide tab to be contacted againstthe inner wall of the guide channel; and a slider protrusion operativelycoupled to a shunt deployment mechanism within the housing.

Clause 81. The delivery device of Clause 80, wherein the guide channelsare disposed about 180 degrees from each other.

Clause 82. The delivery device of any of Clauses 80 to 81, wherein theslider protrusion passes through the housing to the deploymentmechanism.

Clause 83. The delivery device of any of Clauses 80 to 82, wherein thehousing comprises an engagement structure disposed along an outersurface of the housing against which the friction tab can contact thehousing for providing audible or tactile feedback to an operator.

Clause 84. The delivery device of Clause 83, wherein the engagementstructure comprises a groove, an indentation, or a protrusion.

Clause 85. The delivery device of Clause 83, wherein the engagementstructure comprises at least one discontinuity to receive the biasingportion.

Clause 86. The delivery device of Clause 83, wherein the engagementstructure comprises at least one bump on the outer surface of thehousing.

Clause 87. The delivery device of Clause 83, wherein the engagementstructure comprises a plurality of serrated features on the outersurface of the housing.

Clause 88. The delivery device of Clause 83, wherein the engagementstructure comprises a plurality of tapered peaks on the outer surface ofthe housing.

Clause 89. The delivery device of any of Clauses 80 to 88, furthercomprising a hollow needle that comprises a bend at an angle of betweenabout 6 degrees to about 10 degrees and is configured to hold anintraocular shunt.

Clause 90. The delivery device of Clause 89, wherein the bend defines astraight insertion portion and an angled deployment portion of theneedle.

Clause 91. The delivery device of Clause 89, further comprising adeflector component releasably attachable to a distal end portion of thedelivery device, and wherein when the deflector component is coupled tothe delivery device, the hollow needle extends through the deflectorcomponent and the deflector maintains the needle in a bendedconfiguration.

Clause 92. The delivery device of Clause 91, wherein the needle iselastically deformed.

Clause 93. The delivery device of Clause 91, wherein the distal endportion of the delivery device comprises an indexing structure and thedeflector component comprises an alignment index, wherein the alignmentindex of the deflector component can be releasably engaged with theindexing structure to define a rotational orientation of the deflectorcomponent relative to the delivery device.

Clause 94. An inserter device for deploying an intraocular shunt, thedevice comprising: a housing; a shunt deployment mechanism disposedwithin the housing; a deformable hollow needle coupled to the housingand the deployment mechanism for delivering an intraocular shunt; and adeflector component releasably attachable to a distal end portion of thehousing, the deflector component comprising a coupling body and a needleguide positionable against a portion of the needle to cause the needleto be positioned in a bended configuration.

Clause 95. The device of Clause 94, wherein the needle guide comprises abend at an angle of between about 0 degrees to about 15 degrees.

Clause 96. The device of any of Clauses 94 to 95, wherein the needleguide comprises a bend at an angle of between about 2 degrees to about10 degrees.

Clause 97. The device of any of Clauses 94 to 96, wherein the needleguide comprises a bend at an angle of between about 3 degrees to about 8degrees.

Clause 98. The device of any of Clauses 94 to 97, wherein the needleguide comprises a bend at an angle of between about 4 degrees to about 6degrees.

Clause 99. The device of any of Clauses 94 to 98, wherein the needleguide comprises a straight insertion portion and an angled deploymentportion.

Clause 100. The device of any of Clauses 94 to 99, wherein the needle iselastically deformable.

Clause 101. The device of any of Clauses 94 to 100, wherein the housingcomprises an indexing structure and the deflector component comprises analignment index, wherein the alignment index of the deflector componentcan be releasably engaged with the indexing structure to define arotational orientation of the deflector component relative to theinserter device.

Clause 102. The device of Clause 101, wherein the indexing structurecomprises a plurality of index grooves.

Clause 103. The device of Clause 102, wherein the plurality of indexgrooves are configured to receive a plurality of index protrusions ofthe deflector component.

Clause 104. The device of Clause 101, wherein the indexing structuredefines a plurality of orientations at which the deflector component canengage with the housing.

Clause 105. The device of any of Clauses 94 to 104, further comprising aslider component as recited in any of the preceding Clauses.

Clause 106. A method of operating an intraocular shunt inserter, themethod comprising: providing an inserter device for deploying anintraocular shunt, the device comprising a housing having a distal endportion, a shunt deployment mechanism disposed within the housing, and adeformable hollow needle coupled to the housing and the deploymentmechanism for delivering an intraocular shunt; inserting the needle intoa needle guide of a deflector component to cause the needle to bepositioned in a bended configuration; and coupling the deflectorcomponent to the distal end portion of the housing with a coupling bodyof the deflector component positioned against the distal end portion.

Clause 107. The method of Clause 106, wherein the inserting comprisingcausing the needle to be bended at an angle of between about 0 degreesto about 15 degrees in the bended configuration.

Clause 108. The method of any of Clauses 106 to 107, wherein theinserting comprising causing the needle to be bended at an angle ofbetween about 6 degrees to about 10 degrees in the healed configuration.

Clause 109. The method of any of Clauses 106 to 108, wherein theinserting comprising causing the needle to be bended at an angle ofbetween about 2 degrees to about 10 degrees in the bended configuration.

Clause 110. The method of any of Clauses 106 to 109, wherein theinserting comprising causing the needle to be bended at an angle ofbetween about 3 degrees to about 8 degrees in the healed configuration.

Clause 111. The method of any of Clauses 106 to 110, wherein theinserting comprising causing the needle to be bended at an angle ofbetween about 4 degrees to about 6 degrees in the bended configuration.

Clause 112. The method of any of Clauses 106 to 111, wherein the needleguide comprises a straight insertion portion and an angled deploymentportion.

Clause 113. The method of any of Clauses 106 to 112, further comprisingaligning the deflector component with the distal end portion of theinserter via an indexing mechanism.

Clause 114. The method of Clause 113, wherein the indexing mechanismcomprises at least one protrusion on the distal end portion of theinserter.

Clause 115. The method of any of Clauses 113 to 114, wherein thealigning comprises rotationally aligning the deflector componentrelative to the housing.

Clause 116. The method of Clause 115, wherein the rotationally aligningcomprises selecting an indexed rotational position from a plurality ofrotational positions.

Clause 117. A device incorporating any of the features recited in any ofthe preceding Clauses.

Clause 118. A method incorporating any of the features recited in any ofthe preceding Clauses.

Further Considerations

In some embodiments, any of the clauses herein may depend from any oneof the independent clauses or any one of the dependent clauses. In oneaspect, any of the clauses (e.g., dependent or independent clauses) maybe combined with any other one or more clauses (e.g., dependent orindependent clauses). In one aspect, a claim may include some or all ofthe words (e.g., steps, operations, means or components) recited in aclause, a sentence, a phrase or a paragraph. In one aspect, a claim mayinclude some or all of the words recited in one or more clauses,sentences, phrases or paragraphs. In one aspect, some of the words ineach of the clauses, sentences, phrases or paragraphs may be removed. Inone aspect, additional words or elements may be added to a clause, asentence, a phrase or a paragraph. In one aspect, the subject technologymay be implemented without utilizing some of the components, elements,functions or operations described herein. In one aspect, the subjecttechnology may be implemented utilizing additional components, elements,functions or operations.

A reference to an element in the singular is not intended to mean oneand only one unless specifically so stated, but rather one or more. Forexample, “a” module may refer to one or more modules. An elementproceeded by “a,” “an,” “the,” or “said” does not, without furtherconstraints, preclude the existence of additional same elements.

Headings and subheadings, if any, are used for convenience only and donot limit the invention. The word exemplary is used to mean serving asan example or illustration. To the extent that the term include, have,or the like is used, such term is intended to be inclusive in a mannersimilar to the term comprise as comprise is interpreted when employed asa transitional word in a claim. Relational terms such as first andsecond and the like may be used to distinguish one entity or action fromanother without necessarily requiring or implying any actual suchrelationship or order between such entities or actions.

Phrases such as an aspect, the aspect, another aspect, some aspects, oneor more aspects, an implementation, the implementation, anotherimplementation, some implementations, one or more implementations, anembodiment, the embodiment, another embodiment, some embodiments, one ormore embodiments, a configuration, the configuration, anotherconfiguration, some configurations, one or more configurations, thesubject technology, the disclosure, the present disclosure, othervariations thereof and alike are for convenience and do not imply that adisclosure relating to such phrase(s) is essential to the subjecttechnology or that such disclosure applies to all configurations of thesubject technology. A disclosure relating to such phrase(s) may apply toall configurations, or one or more configurations. A disclosure relatingto such phrase(s) may provide one or more examples. A phrase such as anaspect or some aspects may refer to one or more aspects and vice versa,and this applies similarly to other foregoing phrases.

A phrase “at least one of” preceding a series of items, with the terms“and” or “or” to separate any of the items, modifies the list as awhole, rather than each member of the list. The phrase “at least one of”does not require selection of at least one item; rather, the phraseallows a meaning that includes at least one of any one of the items,and/or at least one of any combination of the items, and/or at least oneof each of the items. By way of example, each of the phrases “at leastone of A, B, and C” or “at least one of A, B, or C” refers to only A,only B, or only C; any combination of A, B, and C; and/or at least oneof each of A, B, and C.

It is understood that the specific order or hierarchy of steps,operations, or processes disclosed is an illustration of exemplaryapproaches. Unless explicitly stated otherwise, it is understood thatthe specific order or hierarchy of steps, operations, or processes maybe performed in different order. Some of the steps, operations, orprocesses may be performed simultaneously. The accompanying methodclaims, if any, present elements of the various steps, operations orprocesses in a sample order, and are not meant to be limited to thespecific order or hierarchy presented. These may be performed in serial,linearly, in parallel or in different order. It should be understoodthat the described instructions, operations, and systems can generallybe integrated together in a single software/hardware product or packagedinto multiple software/hardware products.

In one aspect, a term coupled or the like may refer to being directlycoupled. In another aspect, a term coupled or the like may refer tobeing indirectly coupled.

Terms such as top, bottom, front, rear, side, horizontal, vertical, andthe like refer to an arbitrary frame of reference, rather than to theordinary gravitational frame of reference. Thus, such a term may extendupwardly, downwardly, diagonally, or horizontally in a gravitationalframe of reference.

The disclosure is provided to enable any person skilled in the art topractice the various aspects described herein. In some instances,well-known structures and components are shown in block diagram form inorder to avoid obscuring the concepts of the subject technology. Thedisclosure provides various examples of the subject technology, and thesubject technology is not limited to these examples. Variousmodifications to these aspects will be readily apparent to those skilledin the art, and the principles described herein may be applied to otheraspects.

All structural and functional equivalents to the elements of the variousaspects described throughout the disclosure that are known or later cometo be known to those of ordinary skill in the art are expresslyincorporated herein by reference and are intended to be encompassed bythe claims. Moreover, nothing disclosed herein is intended to bededicated to the public regardless of whether such disclosure isexplicitly recited in the claims. No claim element is to be construedunder the provisions of 35 U.S.C. § 112, sixth paragraph, unless theelement is expressly recited using the phrase “means for” or, in thecase of a method claim, the element is recited using the phrase “stepfor.”

The title, background, brief description of the drawings, abstract, anddrawings are hereby incorporated into the disclosure and are provided asillustrative examples of the disclosure, not as restrictivedescriptions. It is submitted with the understanding that they will notbe used to limit the scope or meaning of the claims. In addition, in thedetailed description, it can be seen that the description providesillustrative examples and the various features are grouped together invarious implementations for the purpose of streamlining the disclosure.The method of disclosure is not to be interpreted as reflecting anintention that the claimed subject matter requires more features thanare expressly recited in each claim. Rather, as the claims reflect,inventive subject matter lies in less than all features of a singledisclosed configuration or operation. The claims are hereby incorporatedinto the detailed description, with each claim standing on its own as aseparately claimed subject matter.

The claims are not intended to be limited to the aspects describedherein, but are to be accorded the full scope consistent with thelanguage claims and to encompass all legal equivalents. Notwithstanding,none of the claims are intended to embrace subject matter that fails tosatisfy the requirements of the applicable patent law, nor should theybe interpreted in such a way.

What is claimed is:
 1. A system for deploying an intraocular shunt, thesystem comprising: an intraocular shunt inserter comprising a housinghaving a distal end portion, an indexing structure disposed along thedistal end portion, and a needle extending from the distal end portion;and a deflector component releasably attachable to the distal endportion of the inserter, the deflector component having an alignmentindex and a needle guide configured to receive the needle of theinserter therein, wherein the needle guide maintains the needle in abent configuration, and wherein the alignment index comprises one ormore longitudinally extending grooves indexed relative to the needleguide at a predetermined angle around the longitudinal axis and thatextend radially relative to the housing and can be releasably engagedwith the indexing structure of the housing to define a rotationalorientation of the needle guide relative to the inserter and to resistrotational movement of the deflector component relative to the inserter.2. The system of claim 1, wherein the needle guide comprises a hollowshaft.
 3. The system of claim 1, wherein in the bent configuration, theneedle is bent at an angle of between about 6 degrees to about 10degrees.
 4. The system of claim 1, wherein when coupled with thedeflector component, the needle is elastically deformed.
 5. The systemof claim 1, wherein the indexing structure comprises a plurality ofradially extending index protrusions.
 6. The system of claim 1, whereinthe deflector component comprises a coupler, the needle guide beingattached to the coupler, wherein the alignment index is formed along thecoupler.
 7. The system of claim 6, wherein the alignment index ispositioned along a proximal portion of the coupler.
 8. The system ofclaim 1, wherein the alignment index can be releasably engaged with theindexing structure of the housing to resist longitudinal movement of thedeflector component relative to the inserter to prevent inadvertentdetachment of the deflector component.
 9. The system of claim 1, whereinthe one or more longitudinally extending grooves comprises one or moreindentations or slots.
 10. The system of claim 1, wherein thelongitudinally extending grooves define the rotational orientation ofthe needle guide at the predetermined angle around the longitudinalaxis.
 11. An inserter device for deploying an intraocular shunt, thedevice comprising: a housing having a distal end portion and an indexingstructure extending along the distal end portion; a shunt deploymentmechanism disposed within the housing; a deformable hollow needlecoupled to the housing and the deployment mechanism for delivering anintraocular shunt; and a deflector component releasably attachable tothe distal end portion of the housing, the deflector componentcomprising a coupling body, an alignment index, and a needle guidepositionable against a portion of the needle to cause the needle to bepositioned in a bent configuration, wherein the alignment indexcomprises one or more longitudinally extending index protrusions indexedrelative to the needle guide at a predetermined angle around thelongitudinal axis and that extend radially and can be releasably engagedwith the indexing structure of the housing to define a rotationalorientation of the needle guide relative to the housing and to resistrotational movement of the deflector component relative to the housing.12. The device of claim 11, wherein the needle guide comprises a bend atan angle of between about 0 degrees to about 15 degrees.
 13. The deviceof claim 11, wherein the needle guide comprises a bend at an angle ofbetween about 4 degrees to about 6 degrees.
 14. The device of claim 11,wherein the needle guide comprises a straight insertion portion and anangled deployment portion.
 15. The device of claim 11, wherein theindexing structure comprises a plurality of longitudinally extendingindex grooves that extend radially relative to the housing.
 16. Thedevice of claim 11, wherein the alignment index can be releasablyengaged with the indexing structure of the housing to resistlongitudinal movement of the deflector component relative to theinserter to prevent inadvertent detachment of the deflector component.17. The system of claim 11, wherein the longitudinally extending indexprotrusions define the rotational orientation of the needle guide at thepredetermined angle around the longitudinal axis.
 18. A method ofoperating an intraocular shunt inserter, the method comprising:providing an inserter device for deploying an intraocular shunt, thedevice comprising a housing having an indexing structure extending alonga distal end portion thereof, a shunt deployment mechanism disposedwithin the housing, and a deformable hollow needle coupled to thehousing and the deployment mechanism for delivering an intraocularshunt; inserting the needle into a needle guide of a deflector componentto cause the needle to be positioned in a bent configuration; andcoupling the deflector component to the distal end portion of thehousing with a coupling body of the deflector component positionedagainst the distal end portion; and aligning an alignment index of thedeflector component relative to the indexing structure of the housing todefine a rotational orientation of the needle guide relative to thehousing and resist axial movement of the deflector component relative tothe housing to prevent inadvertent detachment of the deflectorcomponent, wherein the alignment index comprises one or morelongitudinally extending grooves indexed relative to the needle guide ata predetermined angle around the longitudinal axis and that extendradially relative to the housing.
 19. The method of claim 18, whereinthe inserting comprises causing the needle to be bent at an angle ofbetween about 0 degrees to about 15 degrees in the bent configuration.20. The method of claim 18, wherein the inserting comprises causing theneedle to be bent at an angle of between about 6 degrees to about 10degrees in the bent configuration.
 21. The method of claim 18, whereinthe indexing structure comprises a plurality of radially extending indexprotrusions.
 22. The method of claim 21, wherein the aligning comprisesrotationally aligning the deflector component relative to the housing.23. The method of claim 22, wherein the rotationally aligning comprisesselecting an indexed rotational position from a plurality of rotationalpositions.
 24. The method of claim 18, wherein the alignment index canbe releasably engaged with the indexing structure of the housing toresist longitudinal movement of the deflector component relative to theinserter to prevent inadvertent detachment of the deflector component.25. The method of claim 18, wherein the one or more longitudinallyextending grooves comprises one or more indentations or slots.
 26. Themethod of claim 18, wherein the longitudinally extending grooves definethe rotational orientation of the needle guide at the predeterminedangle around the longitudinal axis.